Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Sucralose-based Table-top sweetener [Pellet]: 2 pellet will be used with Lemonade. Single consumption.
Intervention2: Sucralose-based Table-top sweetener [Powder Concentrate]: 1 gm will
Sponsors
Zydus Wellness Products Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Participants who have been recently diagnosed (i.e., within last 5 years) with Type 2 Diabetes Mellitus and are on a stable metformin monotherapy for at-least 3 months prior to screening and also willing to maintain the same dosage throughout the study. 2) Participants having fasting blood glucose levels greater than or equal to 126 mg per dL. 3) Participants having HbA1c level between 6.5 to 8.5 percentage (both inclusive). 4) Participants with Body Mass Index of 23 kilogram per meter square to 27.5 kilogram per meter square (Obesity Grades I & II). 5) Participants who can understand and provide written informed consent to participate in the study. 6) Participants who are willing to refrain from vigorous physical exercise during the study period.
Exclusion criteria
Exclusion criteria: 1) Participants with any known food allergy or intolerance to any food or beverages. 2) Participants with presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g., Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc. 3) Participants with recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study. 4) Participants who have participated in any clinical trial within the past 90 days with blood loss more than 450 ml. 5) Participants who are on an unusual diet, special diet, for whatever reason e.g., high protein diet, low sodium diet, for two weeks prior to receiving any test product and throughout participant s participation in the study. 6) Participants who have performed vigorous physical exercise in the morning on dosing day. 7) Participants who have tested positive for HIV test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the blood glucose response of test products products and one plain lemonade i.e. without any sweetener in diabetic participants.Timepoint: 15 mins prior to product administration and 0, 15, 30, 45, 60, 90 and 120 minutes post product administration on each product administration day. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the delta in blood glucose of test products & one plain lemonade i.e. without any sweetener.Timepoint: Within the two-hour window period after product consumption | — |
Countries
India
Contacts
Public ContactDr Parth Joshi
Cliantha Research
Outcome results
None listed